November 23, 2009
Phase 2b/3 study of Cinquil for pediatric eosinophilic esophagitis (EoE)Ception Therapeutics and Cephalon announced results from a Phase 2b/3 clinical trial for Cinquil (reslizumab) as a treatment for pediatric eosinophilic esophagitis. This four-month, double-blind, placebo-controlled clinical trial evaluated the efficacy and safety of Cinquil in 226 pediatric patients between 5 and 18 years of age with poorly controlled EoE. Study participants were randomized to receive one of three dose levels of Cinquil (1 mg/kg, 2 mg/kg, and 3 mg/kg) or placebo. Co-primary endpoints were improvements in changes in esophageal eosinophil levels and clinical symptoms.
Analyses of the data indicated that patients treated with Cinquil showed a statistically significant reduction (p<0.0001) in esophageal eosinophil levels at all dose levels versus placebo. In the second co-primary endpoint, patients treated with Cinquil showed an improvement in their clinical symptoms. However, placebo treated patients also experienced an unexpectedly large improvement in their symptoms. Therefore, the study did not achieve statistical significance for this endpoint.
Cinquil (reslizumab) is an investigational humanized monoclonal antibody (mAb) against interleukin-5 (IL-5). IL-5 has been shown to play a crucial role in the maturation, growth and chemotaxis (movement) of eosinophils, inflammatory white blood cells implicated in a number of allergic diseases.
For more information call (610) 344-0200 or visit www.cephalon.com.